Clinical Practice Guideline: Blood-Based Biomarkers in Specialty Care

Clinical Practice Guideline: Blood-Based Biomarkers in Specialty Care The Alzheimer's Association’s Blood-Based Biomarker (BBM) Clinical Practice Guideline (CPG) provides evidence-informed recommendations to support specialty health care professionals in effectively incorporating blood-based biomarker testing into Alzheimer’s (AD) diagnosis and management. These guidelines emphasize clear, patient-centered communication, informed consent and practical implementation strategies for use in neurology, geriatrics, psychiatry, memory clinics and other specialty care settings.
 

Background

Recognizing the rapid advancements and clinical potential of blood-based biomarkers for AD detection, the Alzheimer’s Association identified a critical opportunity to provide clear, evidence-informed guidance to health care professionals on their appropriate use in specialty care settings. As BBMs offer a less invasive and more accessible option for detecting AD pathology compared to traditional methods, there was a pressing need to establish standardized clinical practice guidelines to support diagnostic accuracy, patient care and informed decision-making.

  • The guideline development process commenced with formulating precise clinical questions utilizing the PICO (Population, Intervention, Comparison, Outcome) framework to ensure a systematic approach to evidence assessment.

  • Pre-specified diagnostic accuracy thresholds for sensitivity and specificity were established a priori to guide the interpretation of blood-based biomarker tests for both triaging and confirmatory purposes.

  • To capture the most current and relevant evidence, the workgroup conducted a comprehensive systematic review, encompassing peer-reviewed literature published between January 2019 and November 2024.

  • This guideline was developed in accordance with the AGREE II Reporting Checklist and the Guidelines International Network–McMaster Guideline Development Checklist.

  • The panel applied the GRADE framework to appraise the certainty of evidence critically and to balance the benefits, potential harms, patient values and resource implications in formulating recommendations.

  • The development of recommendations was conducted in a blinded manner to mitigate bias concerning specific test names or manufacturers, focusing exclusively on the performance characteristics of the assays.

The BBM CPG explicitly acknowledges limitations inherent in the available data, including heterogeneity among studies and the predominance of single cutoff approaches, and is structured as a living document subject to periodic updates as new evidence emerges. See below for recent updates.

Recommendations

  1. In patients with objective cognitive impairment presenting for specialized memory-care, the panel suggests using a high-sensitivity BBM test as a triaging test in the diagnostic workup of Alzheimer’s disease (conditional recommendation, low certainty evidence).
    • Negative results rule out AD pathology; positive results need confirmation with amyloid PET or CSF AD biomarker analysis.
    • Tests should meet >90% sensitivity and >75% specificity.
  2. In patients with objective cognitive impairment presenting for specialized memory-care, the panel suggests using a high-sensitivity and high-specificity BBM test as a confirmatory test in the diagnostic workup of Alzheimer’s disease (conditional recommendation, low certainty evidence).
    • Negative results rule out AD pathology, positive results rule in AD pathology.
    • Tests should meet >90% sensitivity and >90% specificity.

Contact Us

Questions or feedback about the BBM Clinical Practice Guideline can be directed to:
Malavika Tampi, MPH
Director, Clinical Practice Guidelines
mptampi@alz.org

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